Tennis ElbowPhase 2NCT00130949
ALGRX 4975 in the Treatment of Tennis Elbow
A Phase 2 study testing ALGRX 4975 in people with Tennis Elbow, run by AlgoRx Pharmaceuticals at 1 site in Slovakia.
Trial summary
Tennis elbow is a painful condition that results from repetitive arm movement with overuse of muscles, e.g. when playing tennis. A single injection of ALGRX 4975 has the potential to reduce pain for a period of weeks to months. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Tennis Elbow
- What is being tested?
- ALGRX 4975
- How many people
- 45 participants
- Where
- 1 siteSlovakia
- Study dates
- Nov 2004to Nov 2005
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute lateral epicondylitis (LE) of less than 3 months duration (subjects with recurrent acute LE may be included).
- A screening and baseline severity of pain on resisted wrist dorsiflexion score of moderate or greater intensity.
- Lidocaine responsive.
- A systolic and diastolic blood pressure not greater than 140 and 95 mm Hg, respectively.
Who cannot join
- Any clinically significant form of joint disease, elbow trauma or neuromuscular disorder at the elbow, other than acute LE.
- Physiotherapy treatment within the preceding 2 weeks, prior to Visit 1.
- Any systemic or local corticosteroids within the preceding 3 months, except nasal or inhaled steroids at less than or equal to 1000 mcg/day.
- A medical condition other than LE that requires the use of a pain medication.
- A peripheral sensory or motor neuropathy involving the upper extremities.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase II, Exploratory Evaluation of ALGRX 4975 in Subjects With Acute Lateral Epicondylitis
Tennis elbow is a painful condition that results from repetitive arm movement with overuse of muscles, e.g. when playing tennis. A single injection of ALGRX 4975 has the potential to reduce pain for a period of weeks to months. This study will test the efficacy and safety of ALGRX 4975 in the treatment of patients with tennis elbow.
Read the detailed description
Lateral epicondylitis (tennis elbow) is a painful condition that affects 4 to 7 adults per 1000 annually and tends to involve the subject's dominant side. It typically results from repetitive arm movement with over use of muscles leading to small tears in the tendons attaching muscles of the forearm to the epicondyles that may progress to tendonitis. Pain on or around the lateral epicondyle may radiate down the subject's arm. Gripping or extending the wrist often intensifies the pain.
More than 40 possible treatments have been proposed, reflecting a lack of consensus about optimal management. Non-steroidal anti-inflammatory drugs (NSAIDs) are commonly used to treat tennis elbow, but there are no trials to date that have compared them with other painkillers and one study found no clinically important benefit over placebo. Use of corticosteroid injections provides mixed results in relief of pain and at times insufficient evidence to support their use. Although complications associated with steroid injection are relatively uncommon, when a complication does occur, it can result in severe and disabling consequences for the subject. A small proportion of subjects fail to respond to only one injection of corticosteroid and some subjects who initially improved at four weeks had worse symptoms by six months.
This study has been designed to evaluate the safety and efficacy of a single soft tissue injection of ALGRX 4975 at a dose of 100 µg in comparison to placebo in subjects with acute LE.
- Conditions
- Tennis Elbow
- Being tested
- ALGRX 4975
- Keywords
- Acute lateral epicondylitis, Tennis elbow, Capsaicin
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALGRX 4975Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain induced by resisted wrist dorsiflexion 4 weeks after treatment
Secondary outcomes (8)
Pain induced by resisted wrist dorsiflexion (other than 4 weeks)
Grip strength
Pain experienced during the grip strength test
Pain in elbow over previous 24 hours
Effect on work
Tenderness elicited by investigator or designee
Subjects' global impression of change
Secondary outcomes are evaluated at 1, 2, 4, 8 and 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2005 (estimated)
- Study startNov 2004
- Study completionNov 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tennis ElbowStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 45 participants
Sponsor and investigators
- Lead sponsor
- AlgoRx Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Gabriel Vasko, MD PhD, Principal investigator, Ortopedicko-Traumatologicka Klinika, Kosice, Slovak Republic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00130949
- Sponsor's protocol ID
- 4975-2-005-2
- Other IDs
- Eudra CT No : 2004-001000-12
- Status last verified
- Aug 2005
- First submitted
- 15 Aug 2005
- Last updated
- 20 Dec 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Phase II, Exploratory Evaluation of ALGRX 4975 in Subjects With Acute Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT00130949
- Acronym / sponsor ID
- 4975-2-005-2
- Conditions
- Tennis Elbow
- Keywords
- Acute lateral epicondylitis, Tennis elbow, Capsaicin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants
- Lead sponsor
- AlgoRx PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Nov 2004
- Study completion
- Nov 2005
- First posted
- 17 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Tennis elbow is a painful condition that results from repetitive arm movement with overuse of muscles, e.g. when playing tennis. A single injection of ALGRX 4975 has the potential to reduce pain for a period of weeks to months. This study will test the efficacy and safety of ALGRX 4975 in the treatment of patients with tennis elbow.
Detailed description
Lateral epicondylitis (tennis elbow) is a painful condition that affects 4 to 7 adults per 1000 annually and tends to involve the subject's dominant side. It typically results from repetitive arm movement with over use of muscles leading to small tears in the tendons attaching muscles of the forearm to the epicondyles that may progress to tendonitis. Pain on or around the lateral epicondyle may radiate down the subject's arm. Gripping or extending the wrist often intensifies the pain.
More than 40 possible treatments have been proposed, reflecting a lack of consensus about optimal management. Non-steroidal anti-inflammatory drugs (NSAIDs) are commonly used to treat tennis elbow, but there are no trials to date that have compared them with other painkillers and one study found no clinically important benefit over placebo. Use of corticosteroid injections provides mixed results in relief of pain and at times insufficient evidence to support their use. Although complications associated with steroid injection are relatively uncommon, when a complication does occur, it can result in severe and disabling consequences for the subject. A small proportion of subjects fail to respond to only one injection of corticosteroid and some subjects who initially improved at four weeks had worse symptoms by six months.
This study has been designed to evaluate the safety and efficacy of a single soft tissue injection of ALGRX 4975 at a dose of 100 µg in comparison to placebo in subjects with acute LE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Acute lateral epicondylitis (LE) of less than 3 months duration (subjects with recurrent acute LE may be included).
- A screening and baseline severity of pain on resisted wrist dorsiflexion score of moderate or greater intensity.
- Lidocaine responsive.
- A systolic and diastolic blood pressure not greater than 140 and 95 mm Hg, respectively.
Key exclusion criteria (5 listed)
- Any clinically significant form of joint disease, elbow trauma or neuromuscular disorder at the elbow, other than acute LE.
- Physiotherapy treatment within the preceding 2 weeks, prior to Visit 1.
- Any systemic or local corticosteroids within the preceding 3 months, except nasal or inhaled steroids at less than or equal to 1000 mcg/day.
- A medical condition other than LE that requires the use of a pain medication.
- A peripheral sensory or motor neuropathy involving the upper extremities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALGRX 4975 | Drug | – |
Primary outcome
Pain induced by resisted wrist dorsiflexion 4 weeks after treatment
8 secondary outcomes
Pain induced by resisted wrist dorsiflexion (other than 4 weeks)
Grip strength
Pain experienced during the grip strength test
Pain in elbow over previous 24 hours
Effect on work
Tenderness elicited by investigator or designee
Subjects' global impression of change
Secondary outcomes are evaluated at 1, 2, 4, 8 and 12 weeks.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriel Vasko, MD PhD principal investigator
Ortopedicko-Traumatologicka Klinika, Kosice, Slovak Republic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALGRX 4975 in people with Tennis Elbow, run by AlgoRx Pharmaceuticals at 1 site in Slovakia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Dec 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovakia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain induced by resisted wrist dorsiflexion 4 weeks after treatment. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2006.